Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2.4.6-Trimethylbenzoylchlorid
- Physical state: liquid
- Analytical purity: no data
- Expiration date of the lot/batch: October 1981

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main
- Age at study initiation: no data
- Weight at study initiation: 2.37 - 3.23kg
- Housing: single in steel mesh cages (40x51cm)
- Diet (e.g. ad libitum): SSNIFF standard diet for rabbits (4mm) and Ovator Solikanin (4mm) app. 130g/day and animal
- Water (e.g. ad libitum): app. 250ml per day and animal
- Acclimation period: app. 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26°C
- Humidity (%): 50-80%
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of same animal
Amount / concentration applied:
app. 0.5ml
Duration of treatment / exposure:
3min, 1h, 4h
Observation period:
8 days, observations after 15-30min, 24h, 48h, and 8 days
Number of animals:
8 (3min: 4 females; 1h: 2 females; 4h: 1male, 1female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 X 2.5cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water (1:1)
- Time after start of exposure: after end of exposure, i.e., 3min, 1h, or 4h after start of exposure

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
other: both animals
Time point:
other: 24h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4h exposure, necrosis, animals killed after 24h
Irritation parameter:
erythema score
Basis:
other: both animals
Time point:
other: 24h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4h exposure, necrosis, animals killed after 24h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h, 48h, 8 days
Score:
1.7
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1h exposure, necrosis in both animals
Irritation parameter:
erythema score
Basis:
other: both animals
Time point:
other: 24h, 48h , 8days
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1h exposure, necrosis
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24h, 48h (mean)
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 3min exposure, necrotic spots
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24h, 48h (mean)
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 3min exposure, necrotic spots
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h, 48h (mean)
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 3min exposure, necrosis
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24h, 48h (mean)
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 3min exposure (necrosis)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24h, 48h (mean)
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 3min exposure, severe scale formation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24h, 48h (mean)
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 3min exposure, severe scale formation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24h, 48h (mean)
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 3min exposure, severe scale formation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24h, 48h (mean)
Score:
0.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 3min exposure, severe scale formation

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Conclusions:
After 3min occlusive exposure with the test substance, necrosis was observed after 24h in 2 of 4 rabbits, while all rabbits showed necrotic lesions after longer exposure times. Thus, the substance is corrosive to the rabbit skin.